US FDA licenses Novartis manufacturing facility in Holly Springs, NC

Novartis Vaccines is now selling the first cell-culture influenza vaccine in the US, after the US Food and Drug Administration (FDA) licensed the Novartis manufacturing facility in Holly Springs, North Carolina in June.

The company’s technology uses mammalian animal cells – a method called cell-culture technology – to produce the vaccine, rather than the traditional method that takes place in chickens’ eggs. The main advantage of cell-culture technology, according to Novartis, is that the manufacturing process is more easily controlled and can therefore be quickly ramped up in the event of a pandemic.

'Cell-culture technology is the first major advancement in influenza vaccine production in the US in more than 40 years,' said Andrin Oswald, Division Head at Novartis.

'With this award-winning, state-of-the-art facility, we will be able not only to offer US consumers an antibiotic- and preservative-free alternative for the yearly seasonal flu vaccination, but also be better prepared for future pandemic threats.'

The FDA first approved Novartis’ production of cell-culture vaccines in November 2012, but the licensing of the Holly Springs facility will allow the company to sell the vaccine commercially.

Novartis used cell-culture technology to quickly produce a vaccine candidate for the H7N9 avian flu outbreak in March 2013, and provided a stockpile of the vaccine to the US government.